Qualitum

Validation teams typically spend weeks to quarters producing fragmented evidence across disconnected documents. Qualitum's agents author IQ/OQ/PQ protocols directly from URS, P&IDs and SOP libraries, replace spreadsheet RTMs with a queryable trace graph linking every requirement, test, signature and deviation, and monitor all nine ALCOA+ data-integrity criteria on every record. Humans review and approve; the audit trail is a byproduct, not an afterthought. Qualitum runs single-tenant on AWS, Azure or on-prem, with customer-managed keys and no training rights on customer data, and connects to systems of record already in use (Veeva, MasterControl, TrackWise, AVEVA PI, Tulip and others).

Ideal users: Heads of Validation and validation consultancies at pharma, biotech and medical-device companies.